Risk Management Tools & Resources

The patient was a 42-year-old female with a history of HPV, infertility, yeast infections, and abnormal Pap smears. She presented to her OB/GYN's clinic for a routine Pap smear. It had been a little more than 2 years since her last Pap smear, which had been negative. The tissue sample was taken and, for reasons not known, sent to a private diagnostic laboratory, rather than the hospital laboratory (as was the normal practice). The laboratory returned findings of endocervical adenocarcinoma in situ.

Dr. A reviewed the test results and entered the findings into the electronic health record (EHR). He then gave the results to a nurse and instructed her to contact the patient to schedule an appointment as soon as possible. Unfortunately, no one from the clinic contacted the patient about the abnormal results.

The patient returned to the clinic for her routine checkup 2 years later. At that time, it was discovered that no one had followed up about the previous abnormal results. A thorough examination was done at that time, including a colposcopy.

The results from the colposcopy continued to indicate endocervical adenocarcinoma in situ, and a prompt referral was made to Dr. B, a gynecologist-oncologist. A CT scan of the patient's pelvis and abdomen indicated a cervical mass extending from her upper vagina to the lower uterine segment.

Because of the extent of the cancer, Dr. B promptly performed a robotic radical hysterectomy, bilateral salpingo-oophorectomy, complete pelvic node dissection, and low para-aortic lymph node sampling (this was one of Dr. B's first uses of the robot for this procedure). The final staging of the adenocarcinoma was T1B2, N0, MX.

Initially, the patient did well following surgery; however, she later developed complications, including bilateral pulmonary emboli and pleural effusions, abdominal infection and ileus, and a large abdominal hematoma. Multiple hospital admissions followed (including some to the intensive care unit) before she fully recovered. Fortunately, she did fully recover, and has had no recurrence of the cancer.

The patient filed a medical malpractice lawsuit against Dr. A and his clinic only, which was settled out of court.

Discussion

Various issues contributed to the delayed diagnosis of cancer and suboptimal patient outcome in this case. The first issue relates to how the initial tissue sample was handled. The clinic's normal process was to send all specimens to the local hospital for analysis.

The local hospital had implemented two very beneficial safety procedures to minimize the risk of tests "falling through the cracks." The first safeguard was a "check-back" system. After notifying the physician of an abnormal test result, the hospital would follow up with the physician within a given timeframe (such as 30 days) if no further specimens from that particular patient were received.

The second safety procedure was a quarterly report to the physician, which listed all of the abnormal results that had been reported to him/her in the preceding quarter. This would give the physician an opportunity to check the report against each patient's EHR to verify that appropriate action had been taken in each case.

Unfortunately, in this case, the clinic's normal procedure was not followed, and the patient's specimen was sent to an outside laboratory that did not use similar safety procedures. Further, the clinic missed another important opportunity by not utilizing the patient as part of the follow-up process.

Although a typical practice may handle thousands of specimens per month, a patient rarely has more than one or two test results pending. The practice can easily tell a patient, "We will contact you within 2 weeks with the results of your test. If, by chance, you do not hear from us by then, please call us and inquire about your results." By using this approach, rather than the "no news is good news" approach, the practice adds an additional level of scrutiny and redundancy to the reporting process.

Another important issue is the learning curve associated with the use of new technology of any sort. In this case, Dr. A's clinic had just transitioned to a new EHR system, and Dr. A was still adjusting to it. Experience has shown that the EHR conversion/transition period is a time of significantly elevated risk for the loss of information, failure to follow up, etc. Exercising special caution during this transitional time is very important, as is using the system's alerts and ability to run reports of outstanding test results.

The learning curve also applies to equipment used in the actual treatment of patients. Experts who reviewed the case speculated that Dr. B's limited experience with robotic surgery may have contributed to some of the patient's complications following surgery. Further, complications might have been avoided if a simple, rather than a radical, hysterectomy had been performed. (Radical hysterectomies have a greater risk of complications than simple hysterectomies.) However, because a simple hysterectomy would have been indicated if the diagnosis had been made on the earlier date, any problems with the eventual surgery could not be used in the defense of this case.

In Summary

Errors and oversights in test tracking and follow-up are a persistent patient safety and risk management concern. Although eliminating errors entirely is unrealistic, healthcare organizations and providers can take advantage of strategies and systems designed to minimize the potential for error and maximize the safe delivery of patient care.

Examples of these strategies and systems include (a) developing and adhering to well-defined test tracking protocols, (b) engaging patients in the follow-up process by encouraging them to contact the provider if they do not receive results within a specific timeframe, (c) taking extra precaution when new technology is introduced as part of administrative processes or patient care, and (d) using technology to provide additional safeguards in the test tracking and follow-up processes (e.g., through the use of reminders and notifications for high-alert test results or high-risk patients).

As the nation’s first provider of healthcare liability insurance, MedPro Group has protected the assets and reputations of the healthcare community since 1899. With over $1 billion in annual premium and more than 200,000 clients, MedPro Group is the national leader in customized insurance, claims and patient safety & risk solutions for physicians, surgeons, dentists and other healthcare professionals, as well as hospitals, senior care and other healthcare facilities.